NL-OMON56399招募中2 期
A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis (PSC) and suspected liver fibrosis (INTEGRIS-PSC) - PLN-74809-PSC-203
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria:
- •General and Administrative
- •1. Aged 18 to 75 years, inclusive.
- •2. Female participants of childbearing potential must use a contraceptive
- •method with a failure rate of <1% per year or remain abstinent (refrain from
- •heterosexual intercourse) during the treatment period and for 1 month after the
- •last dose of study drug.
- •Male participants with female partners of childbearing potential must agree to
- •use contraceptive measures or remain abstinent (refrain from heterosexual
- •intercourse) during screening and the treatment period and for at least 3
- •months after the last dose of study drug.
- •3. Female participants of nonchildbearing potential must be surgically sterile
- •or postmenopausal.
- •4. Participants must agree to abstain from sperm or egg donation for the
- •duration of the study, through 3 months or 1 month, respectively, after
- •administration of the last dose of study drug.
- •5. Able to understand the purpose and procedures that are involved in the study
- •and willing to sign a written informed consent form.
- •Primary Sclerosing Cholangitis Diagnosis
- •6. Established clinical diagnosis of large duct PSC based on an abnormal
- •cholangiography as assessed by magnetic resonance cholangiopancreatography
- •(MRCP), endoscopic retrograde cholangiopancreatography (ERCP), and/or
- •percutaneous transhepatic cholangiopancreatography (PTC) in the context of
- •elevated cholestatic liver chemistries.
- •7. Serum alkaline phosphatase concentration within normal ranges or > 1 × the
- •upper limit of normal (ULN).
- •8. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase
- •(ALT) concentration <= 5 × ULN.
- •9. Serum total bilirubin <= 1.5 × ULN, in the absence of hemolysis.
- •Participants with serum total bilirubin > 1.5 × ULN may be enrolled if they
- •have Gilbert*s Syndrome and a direct bilirubin < 0.6 mg/dL.
- •10. Suspected liver fibrosis, as defined by any of the following:
- •- Enhanced Liver Fibrosis (ELF) Score >= 7.7 at Screening OR
- •- Liver stiffness measurement (LSM) >= 8 kPa but <= 14.4 kPa, assessed by
- •FibroScan® OR
- •- Historical liver biopsy showing fibrosis without cirrhosis (by any scoring
- •- Magnetic resonance elastography (MRE) >= 2.4 kPa but <= 4.9 kPa
- •11. Platelet count >= 140,000/mm3.
- •12. Albumin >= 3.3 g/dL.
- •13. International normalized ratio (INR) <= 1.3 in the absence of anticoagulant
- •14. Serum carbohydrate antigen 19-9 (CA19-9) value <= 130 U/mL.
- •Prior and Concomitant Medications
- •15. If receiving treatment with UDCA, therapy is at a dose of < 25 mg/kg/day,
- •has been stable for at least 3 months before screening, will remain stable from
- •screening through Day 1 (baseline), and is expected to remain stable for the
- •duration of the study.
- •16. If receiving allowed concomitant medications for the treatment of IBD,
- •therapy must be stable from screening and expected to remain stable for the
- •duration of the study.
- •Medical History and Comorbid Conditions
- 另有 6 项未显示
排除标准
- •Exclusion Criteria:
- •Primary Sclerosing Cholangitis Diagnosis
- •1. Other causes of liver disease, including secondary sclerosing cholangitis or
- •viral, metabolic, or alcoholic liver disease, as assessed clinically.
- •2. Known or suspected overlapping clinical and histologic diagnosis of
- •autoimmune hepatitis.
- •3. Small duct PSC with no evidence of large duct involvement (evidence of PSC
- •on historical liver histology, with normal bile ducts on cholangiography).
- •Liver Disease Status
- •4. Presence of a clinically significant dominant stricture based on the
- •combination of radiological, biochemical, and clinical features.
- •5. Presence of a percutaneous drain or bile duct stent.
- •6. Serum alkaline phosphatase (ALP) concentration > 10 times ULN.
- •7. Worsening of liver disease, defined as 2 consecutive ALP, ALT, or AST
- •measurements obtained >= 2 weeks apart during the screening period that increase
- •by > 30% and represent either a Common Terminology Criteria for Adverse Events
- •(CTCAE) Grade 1 that is associated with new or worsening symptoms or a CTCAE
- •Grade 2 with or without new or worsening symptoms, as defined by CTCAE Version
- •8. Ascending cholangitis within 60 days of screening, as assessed clinically or
- •use of antibiotics for acute cholangitis within 60 days of screening.
- •9. IgG4-associated cholangitis.
- •10. Positive anti-mitochondrial antibody.
- •11. Presence of liver cirrhosis as assessed by historical liver histology,
- •ultrasound based liver stiffness measurement (FibroScan® value > 14.4 kPa), MRE
- •> 4.9 kPa, and/or signs and symptoms of hepatic decompensation (including, but
- •not limited to, jaundice, ascites, variceal hemorrhage, and/or hepatic
- •encephalopathy).
- •12. Presence of hepatic impairment, end-stage liver disease, and/or a model for
- •end stage liver disease (MELD) score >= 15.
- •13. Prior or planned liver transplantation during the study.
- •Medical History and Comorbid Conditions
- •14. Presence of end-stage renal disease that requires dialysis.
- •15. History, current clinical or radiological suspicion, or diagnosis of
- •cholangiocarcinoma, other hepatobiliary malignancy, colorectal cancer, or other
- •abdominal malignancy at any time.
- •16. Human immunodeficiency virus (HIV), hepatitis A virus, hepatitis B virus,
- •and/or hepatitis C virus infection, with the exception of those who have been
- •successfully treated for hepatitis C infection and have achieved sustained
- •virologic response for >= 1 year
- •17. History of malignancy within the past 5 years or ongoing malignancy other
- •than basal cell carcinoma, resected noninvasive cutaneous squamous cell
- •carcinoma, or treated cervical carcinoma in situ.
- •18. Clinical evidence of active bacterial, viral, or fungal infection that
- •required antibiotic or antifungal therapy within 30 days before screening.
- •19. History of unstable or deteriorating cardiac disease within the previous 6
- •months, including, but not limited to:
- •a. Unstable angina pectoris or myocardial infarction
- •b. Congestive heart failure requiring hospitalization
- •c. Uncontrolled clinically significant arrhythmias
- •d. Clinically significant electrocardiogram (ECG) abnormalities, including but
- 另有 3 项未显示
研究者
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